Novartis had applied for Class 1 reimbursement of a specific drug for adult patients with myelofibrosis.
The company asked hict for support in the pharmaco-economic section of this reimbursement submission.
This support includes:
- Collection of the necessary Belgian cost data for the CEA model
- Critical review of the CEA model and (clinical) inputs
- Population of the CEA model with the collected data, and generation of results
- Development of a CEA report
hict’s approach consisted of the following four phases:
Phase 1 – Intake phase
During the intake phase, the context, strategy and key parameters of the submission and CEA model were discussed and analysed. An in-depth analysis of the provided CEA model, data inputs and sources of this model was performed. Based on the model requirements a complementary high-level desk research was performed and a gap analysis outlining the missing data and potential data sources was provided. This gap analysis served to identify the optimal data collection approach to be used during the data collection phase.
Phase 2 – Data collection
The data collection phase is designed to capture relevant Belgian inputs for the CEA model and was comprised of 3 sub phases:
- desk research (e.g. MZG-MKG national data, literature, etc.)
- expert opinion
- Development of 2 surveys: one on the clinical practice of myelofibrosis in Belgium and one on the treatment of AEs
- Processing of all data
- Interviews with 4 experts to discuss the results of the surveys
- Development of 2 reports
- Expert opinion report on the clinical practice
- AE cost report
- Collection of unit costs out of national databases.
Phase 3 – CEA model support
During the CEA model support phase, the data collected during the intake and data collection phase was used to adapt the model to the Belgian context and populate the model with Belgian data. Results were generated (conform strategy on base case and scenario analyses) and discussed extensively with the pharmaceutical company.
Phase 4 – CEA report support
During this phase a CEA report was developed that is in line with the overall reimbursement strategy, meets KCE guidelines and is comprehensible for all readers.
- Gap-analysis between required data and available data.
- Kick-off meeting in which strategy of CEA model and reimbursement submission is determined in cooperation with the client.
- Data collection of all key information to populate the CEA model (including specification of the sources).
- Survey on the current Belgian clinical practice.
- Survey on the current Belgian resource use necessary to treat specific AEs.
- A transparent and detailed AE cost calculation model in excel, consisting of the resource use obtained from the experts, the derived resource use consensus, the unit costs and the total cost calculation.
- Expert opinion report: a report describing the applied methodology, questions asked, results obtained and conclusions made.
- AE cost report: a report structurally presenting how the AE costs are determined (including the applied methodology) and discussing the resource use, unit costs and total cost for each AE.
- A validated and populated CEA model, adapted for Belgium
- A clear and validated CEA report conform the KCE guidelines, describing the model, methodology, analyses (deterministic, PSA, OWSA), data inputs and results.